Open-Label Study to Evaluate the Inter-subject Variability of Single Dose Prolia Pharmacokinetics and Pharmacodynamics, Administered by Subcutaneous Injection in Healthy Postmenopausal Women

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000728831

Enrollment

Registered

2021-06-10

Start date

2021-07-14

Completion date

2021-08-31

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Single-center, single-arm, open-label study of Prolia administered subcutaneously in healthy post menopausal women. The study is designed to provide single-dose pharmacokinetic inter-subject variability data for prolia, to optimize study design (including sample size calculation) for a proposed Prolia biosimilar pivotal PK study.

Interventions

Approximately 20 healthy post menopausal women will each receive a single 6mg dose of Prolia, as an injection under the skin in the abdomen. The SC injection will be given by a registered nurse.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, active malignancy, renal disease Previous treatment with denosumab. Receipt of any therapy that may significantly affect bone turnover, e.g., bisphosphonates within 12 months; or estrogens, selective estrogen receptor modulators, calcitonin, parathyroid hormone, high doses of Vitamin D (Greater than 1,000 IU daily), anabolic steroids, systemic glucocorticosteroids, or calcitriol within 6 months prior to IP administration. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery within 6 months prior to IP administration), poor oral hygiene, periodontal, and/or pre-existing dental disease. .Evidence of hypocalcaemia, Known vitamin D deficiency. Any current active infection, Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Human Immunodeficiency Virus (HIV) at screening. A recent history of major surgery (within 3 months prior to IP administration). History or presence of malignancy

Exclusion criteria

Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, active malignancy, renal disease Previous treatment with denosumab. Receipt of any therapy that may signi?cantly affect bone turnover, e.g., bisphosphonates within 12 months; or estrogens, selective estrogen receptor modulators, calcitonin, parathyroid hormone, high doses of Vitamin D (Greater than 1,000 IU daily), anabolic steroids, systemic glucocorticosteroids, or calcitriol within 6 months prior to IP administration. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery within 6 months prior to IP administration), poor oral hygiene, periodontal, and/or pre-existing dental disease. .Evidence of hypocalcemia, Known vitamin D deficiency. Any current active infection, Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Human Immunodeficiency Virus (HIV) at screening. A recent history of major surgery (within 3 months prior to IP administration). History or presence of malignancy

Outcome results